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A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT01076517
Expanded Access Status : Approved for marketing
First Posted : February 26, 2010
Last Update Posted : April 1, 2021
BTG International Inc.
Information provided by (Responsible Party):
Daniel Yung-Ho Sze, Stanford University

Brief Summary:
To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.

Condition or disease Intervention/treatment
Liver Cancer Device: Therasphere

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Study Type : Expanded Access
Official Title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Therasphere
    Beta-emitting 90yttrium encapsulated in glass microspheres for intraarterial administration to the liver.
    Other Names:
    • HCC
    • hepatocellular carcinoma treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients of any age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of </= 2, with a life expectancy of >/= 3 months, non-pregnant with an acceptable contraception in premenopausal women. Patients must be >4 weeks since prior radiation or prior surgery and at least 1 month post other chemotherapy.

Exclusion Criteria:

  • Contraindications to angiography and selective visceral catheterization
  • Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs
  • Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels)
  • Significant extrahepatic disease representing an imminent life-threatening outcome
  • Severe liver dysfunction or pulmonary insufficiency
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness
  • Pregnancy

Patients will be excluded: if they have a co-morbid disease or an acute or chronic condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076517

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
BTG International Inc.
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Principal Investigator: Daniel Yung-Ho Sze Stanford University
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Responsible Party: Daniel Yung-Ho Sze, Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01076517    
Other Study ID Numbers: IRB-14324 (NOT RESEARCH)
HEP0016 ( Other Identifier: OnCore )
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases